510(k) · Cleared

Cleared

Degudent GS

K905387510(k) TraditionalCleared Jan 15, 199146-day reviewClass II21 CFR 872.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Degussa AG · EJT Alloy, Gold-Based Noble Metal

Cleared on Jan 15, 1991 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jan 15, 1991
Review: 46 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK905387 Degudent GSDegussa AG · 1991
Descendant · cites it directly · 0 of its ownK023199 Ceranum 50Sb Lucius, Inc. · 2002
Descendant · cites it directly · 0 of its ownK021947 Ceranum 87Lucius Metals Com. · 2002

Most influential descendants

Showing 2 of 2 · See all

K023199Ceranum 50Sb Lucius, Inc. · 2002 · cites it directly0descendants
K021947Ceranum 87Lucius Metals Com. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K905387	Degudent GS	Degussa AG	1991	—
+1	K023199	Ceranum 50	Sb Lucius, Inc.	2002	—
+1	K021947	Ceranum 87	Lucius Metals Com.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0

FIG. 1 — Lineage of K905387, 1991–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023199	Ceranum 50	Sb Lucius, Inc.	2002	0
K021947	Ceranum 87	Lucius Metals Com.	2002	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K023199 (Sb Lucius, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EJT devices

EJT Alloy, Gold-Based Noble Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EJT

FDA has decided no EJT device since 2007.

Median 510(k) review, days · EJT

Too few EJT 510(k)s in any year since 2007 to give a median.

Recalls per year · EJT

No recall names EJT since 2007.

Adverse event reports per year · EJT

1in 2017

2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code EJT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	1
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K905387 · printed Nov 3, 2026

Cite this page

510(k) Report. “K905387: Degudent GS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K905387

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026